drugset / Trial / NCT00474110

Ketamine and Hydromorphone for Patient Controlled Pain Relief in Children's Mucositis

NCT00474110

Phase 3 Withdrawn University of British Columbia
Non-randomizedSingle-groupOpen-labelTreatment

Summary

The treatment of cancer in children may result in an extremely painful condition called oral mucositis when the cells lining the mouth are injured due to the cancer medication. Patients with this condition are often unable to take anything by mouth or to swallow their own saliva. This severe pain may last for as long as 2 weeks. A survey of our previous 22 patients showed high daily pain scores despite the use of intravenous (given through a small tube in a vein) opioid medications (family of pain relieving drugs, e.g. morphine and hydromorphone). The purpose of this pilot study is to determine which of 3 concentrations of ketamine to combine with hydromorphone to provide the best pain relief with minimum side effects. The results from this study will allow us to do a larger study to compare the best concentration found from this study to standard treatment. If successful, this combination of ketamine and hydromorphone will also be used to treat other pain problems in children.

Timeline

Start
2009-08
Primary completion
2011-12
Completion
2011-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Hydromorphone Other / unclassified 0.2 mg/ml Other
Subject Ketamine Small molecule 0.2 mg/ml Other
Subject Ketamine Small molecule 0.6 mg/ml Other
Subject Ketamine Small molecule 1 mg/ml Other

Indications